by
Rebecca Stauffer, PDA | Jul 09, 2018
Check Out the Latest in New Technology Advancements in the PDA Journal
The July/August issue of the PDA Journal of Pharmaceutical Science and Technology features two articles spotlighting new technologies and
applications. One looks at ozone generation during high-voltage leak detection and the other explores human factors for Ranibizumab
0.5 mg prefilled syringes.
Research
- Yuh-Fun Maa, et al., “Vapor Phase Hydrogen Peroxide
Decontamination or Sanitization of an Isolator for Aseptic Filling of
Monoclonal Antibody Drug Product—Hydrogen Peroxide Uptake
and Impact on Protein Quality“
- Alejandra Nieto, Holger Roehl, “Sealing Behaviour of Container
Closure Systems under Frozen Storage Conditions: Nonlinear Finite
Element Simulation of Serum Rubber Stoppers“
- Alberto Chillon, et al., “Introducing the Alba® Primary Packaging
Platform. Part 1: Particle Release Evaluation”
- Alavattam Sreedhara, et al., “Determination of the Acceptable
Ambient Light Exposure during Drug Product Manufacturing for
Long-Term Stability of Monoclonal Antibodies“
Technology/Application
- Martin Becker, et al., “Ozone Generation during High-Voltage Leak
Detection: Fiction or Reality?“
- Andrew Antoszyk, et al., “Usability of the Ranibizumab 0.5 mg
Prefilled Syringe: Human Factors Studies To Evaluate Critical Task
Completion by Healthcare Professionals“
Case Study
- Yushi Uetera, et al., “The Role of Heat-Tolerant Endotoxin-Retentive Ultrafilters (UFs) for the Remediation of Reverse Osmosis (RO) Plants Employed
for Surgical Hand Antisepsis Using Periodic Thermal Disinfection—A Ten Year Longitudinal Experience Study in the Operating Theater“
Commentary
- Kyle Zingaro, David Shaw, et al., “Implementation of Plate Imaging for Demonstration of Monoclonality in Biologics Manufacturing
Development“
Erratum
- John Mattila, et al., “ERRATUM: Retrospective Evaluation of Low-pH Viral Inactivation and Viral Filtration Data from a Multiple Company
Collaboration“